Multi-window guide tunnel

ABSTRACT

Described herein are devices and methods for delivering implants that comprise multiple coupled anchors. The anchors are secured to tissue using a multi-opening guide tunnel that is configured to releasably retain one or more portions of the implant located between two of the anchors. The releasable retention of one or more intervening portions of the implant maintains the position of the implant and the guide tunnel until the implant is secured to the tissue. The multi-opening guide tunnel permits securement of the multiple anchors without requiring repositioning of the guide tunnel for each anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S.application Ser. No. 12/366,553, filed Feb. 5, 2009, now issued as U.S.Pat. No. 8,790,367, which claims priority under 35 U.S.C. §119(e) toU.S. Provisional Application No. 61/026,697, filed Feb. 6, 2008, thecontents of each of which are hereby incorporated by reference in theirentirety.

BACKGROUND OF THE INVENTION

Blood returning to the heart from the peripheral circulation and thelungs generally flows into the atrial chambers of the heart and then tothe ventricular chambers, which pump the blood back out of the heart.During ventricular contraction, the atrio-ventricular valves between theatria and ventricles, i.e. the tricuspid and mitral valves, close toprevent backflow or regurgitation of blood from the ventricles back tothe atria. The closure of these valves, along with the aortic andpulmonary valves, maintains the uni-directional flow of blood throughthe cardiovascular system. Disease of the valvular apparatus can resultin valve dysfunction, where some fraction of the ventricular bloodregurgitates back into the atrial chambers.

Traditional treatment of heart valve stenosis or regurgitation, such asmitral or tricuspid regurgitation, involves an open-heart surgicalprocedure to replace or repair the valve. Current accepted treatments ofthe mitral and tricuspid valves include: valvuloplasty, in which theaffected leaflets are remodeled to perform normally; repair of thechordae tendineae and/or papillary muscle attachments; and surgicalinsertion of an “annuloplasty” ring, which requires suturing a flexiblesupport ring over the annulus to constrict the radial dimension. Othersurgical techniques to treat heart valve dysfunction involve fastening(or stapling) the valve leaflets to each other or to other regions ofthe valve annulus to improve valve function (see, e.g., U.S. Pat. No.6,575,971).

BRIEF SUMMARY OF THE INVENTION

Described herein are devices and methods that involve attachment sites,including implants with multiple coupled anchors. The anchors may besecured to tissue using a multi-opening guide tunnel that is configuredto releasably retain one or more portions of the implant located betweentwo anchors, such as a tether component that attach the anchors. Thereleasable retention of one or more interconnecting portions of theimplant provides additional stabilization for the delivery tool untilthe implant is secured to the tissue. The multi-opening guide tunnelpermits securement of the multiple anchors without requiringrepositioning of the guide tunnel for each anchor. In some embodiments,the multi-opening guide tunnel comprises disengageable wall segmentsbetween the openings of the guide tunnel, which provide structuralsupport and column strength in a region of the guide tunnel that wouldbuckle or collapse due to the number of openings and theirconfiguration.

In some embodiments, a system for use in a patient is provided,comprising an outer catheter, which comprises a passageway with aproximal end, a distal end, a longitudinal axis and two or more outeropenings, and at least one releasable retaining structure locatedbetween the two or more outer openings. At least one releasableretaining structure may be adapted to open a release channel between twoor more outer openings. In some instances, at least two of the two ormore outer openings are two adjacent outer openings with a separationdistance less than a maximum dimension of one of the two adjacent outeropenings, and at least one releasable retaining structure is locatedbetween the two adjacent outer openings. In some variations, two or moreouter openings are longitudinally spaced along a longitudinal length ofthe outer catheter, and may be configured for passage of a tissueanchor. At least one releasable retaining structure may be configured toretain a tether attached to the tissue anchor, and is optionally anouter wall structure of the outer catheter. The outer catheter maycomprise at least three outer openings, and optionally at least tworeleasable retaining structures. The system may further comprise aninner catheter slidably located in the passageway of the outer catheter,and sometimes may further comprise an alignment interface between theouter catheter and the inner catheter. The alignment interface maycomprise a rail, which may be a metallic material and/or may be securedto the outer catheter at two or more securing sites. The outer cathetermay also further comprise a curved configuration having a lessercurvature and a greater curvature, and in some embodiments, two or moreopenings may be generally located along the greater curvature of theouter catheter. The outer catheter may also comprise an atraumatic tip.The catheter may further comprise at least one radio-opaque structurelocated between the two or more outer openings. The inner catheter maycomprise an inner opening and wherein the inner guide and outer guideare configured to permit positioning of the inner opening at two or moreouter openings. In some embodiments, at least one releasable retainingstructure comprises a locking passage. The at least one locking elementmay be configured for removable positioning in the locking passage of atleast one releasable retaining structure, and at least two releasableretaining structures with locking passages are both optionallyconfigured for removable positioning by one of the at least one lockingelements.

In other embodiments, an implant delivery system is provided, comprisinga catheter body which comprises a proximal end, a distal end, alongitudinal lumen therebetween, a lumenal surface, an ablumenalsurface, and at least one implant delivery opening in communication withthe longitudinal lumen and located between the luminal surface and theablumenal surface, and at least two longitudinally-spaced retentionmembers located distal to the proximal end of the catheter body. In someinstances, at least two longitudinally-spaced retention members arelocated within the longitudinal lumen, or within the at least oneimplant delivery opening. At least two longitudinally-spaced retentionmembers may have a transverse orientation with respect to thelongitudinal lumen. In some embodiments, at least twolongitudinally-spaced retention members are movable retention members,which may be rotatable or flexible retention members. The movableretention members may each comprise a through lumen. The implantdelivery system may further comprise a first anchor coupled to a tether,and in some instances at least two longitudinally-spaced retentionmembers are configured to retain the tether.

In another embodiment, a method for securing anchors to a body structureis provided, comprising providing an implant comprising a first anchor,a second anchor, and a first coupling portion therebetween, passing thefirst anchor and the second anchor into a common lumen of a catheter,deploying the first anchor through a first opening of the catheter,deploying the second anchor through a second opening of the catheter,retaining the first coupling portion of the implant in the catheter,wherein the first coupling portion is located between two anchorssecured to the body structure, and releasing the first coupling portionof the implant from the catheter after securing the first anchor and thesecond anchor to body tissue. The method may further comprisepositioning the catheter in a subvalvular space of a ventricle. In someinstances, releasing the first coupling portion of the implant from thecatheter may comprise disengaging a wall section of the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The structure and method of using the invention will be betterunderstood with the following detailed description of embodiments of theinvention, along with the accompanying illustrations, in which:

FIG. 1 is a cross-sectional view of a heart with a guide catheter deviceadvanced through the aorta into the left ventricle;

FIG. 2 is a flowchart representation of a method for delivering at leasttwo anchors into a subvalvular region;

FIGS. 3A to 3I schematically depict a method for delivering multipletissue anchors using a guide tunnel having multiple tissue openings;

FIGS. 4A and 4B illustrate the use of various tissue anchors with aguide tunnel having multiple tissue openings; FIG. 4C shows the use ofthe guide tunnel in the coronary sinus;

FIGS. 5A to 5D are cross-sectional views of a portion of a heart,schematically illustrating the positioning and deployment of a flexibledevice for treatment of a mitral valve annulus;

FIGS. 6A to 6C are schematic cross-sectional views of one embodiment ofthe invention comprising a self-forming anchor attaching to tissue;

FIG. 7A depicts one embodiment of a multi-opening guide tunnel; FIG. 7Bdepicts the multi-opening guide tunnel of FIG. 7A with its latchesunlocked and separated from the body of the guide tunnel; FIG. 7Cillustrates one embodiment of an inner guide tunnel usable with themulti-opening guide tunnel of FIG. 7A; FIGS. 7D and 7E are schematiccross-sectional views of the multi-opening guide tunnel at variouslocations;

FIGS. 8A to 8D represent various embodiments of a latch; FIGS. 8E and 8Fare schematic representations of various locking lumens for a latch;

FIGS. 9A and 9B are schematic illustrations of various locking wireembodiments;

FIGS. 10A and 10B schematically depict various latch and openingconfigurations for a guide tunnel;

FIG. 11 is a perspective view of a distal portion of one embodiment ofan anchor delivery catheter;

FIGS. 12A and 12B are perspective views of a distal portion of anotherembodiment of an anchor delivery catheter;

FIG. 13A is a perspective view of another embodiment of a deliverycatheter, FIG. 13B is a frontal view of the delivery catheter of FIG.13A, and FIGS. 13C and 13D are side and bottom views, respectively, of aportion of the delivery catheter of FIG. 13A;

FIGS. 14A to 14H are various perspective views of one embodiment of amulti-opening guide tunnel;

FIGS. 15A to 15F schematically demonstrate a method for applying anchorsfrom the subvalvular space;

FIGS. 16A and 16B are schematic top-views of a plurality of anchorscoupled to a self-deforming coupling member, with the coupling membershown in an undeployed shape and a deployed shape, respectively;

FIG. 17 shows a transseptal approach to the left ventricle;

FIG. 18 shows a transapical approach to the left ventricle;

FIG. 19 is a schematic view of the heart illustrating various dimensionsof a heart chamber;

FIG. 20 is schematic view of the heart illustrating various dimensionsof a heart chamber;

FIG. 21 depicts the use of a multi-opening guide tunnel along alongitudinal portion of the left ventricle;

FIGS. 22A and 22B represent another embodiment of a guide tunnel;

FIGS. 23A and 23B represent still another embodiment of a guide tunnel;

FIG. 24 is a schematic side view of another embodiment of a guide tunnelwith openings comprising non-orthogonal edges;

FIG. 25A is a perspective views of one embodiment of a hemostatic seal;FIG. 25B is an posterior elevational view of the seal of FIG. 25A; FIG.25C is a cross-sectional view of the seal in FIG. 25B; and

FIG. 26 is a posterior elevational view of an alternate sealconfiguration.

DETAILED DESCRIPTION OF THE INVENTION

Although a number of surgically implanted ventricular devices andprocedures, such as the implantation of an annuloplasty ring oredge-to-edge leaflet repair, are available for treating valvulardysfunction, each procedure presents its own set of risks to the patientor technical challenges to the physician. For example, the ability toaccurately and reliably position a cardiac implant during a beatingheart procedure, whether by open chest or minimally invasive access,remains elusive to the average practitioner. In particular, thepercutaneous or transvascular implantation of a ventricular devicedescribed herein poses a significant challenge due to the instabilityfrom the wall motion of a beating heart.

Devices, systems and methods of the instant invention are generally usedto reshape atrio-ventricular valves or myocardium to improve hemodynamicperformance. The implantation procedures are preferably transvascular,minimally invasive or other “less invasive” surgical procedures, but canalso be performed with open or limited access surgical procedures. Whenused for treatment of a cardiac valve dysfunction, the methods generallyinvolve positioning one or more anchor delivery devices at a target siteusing a guide tunnel, delivering a plurality of slidably coupled anchorsfrom the delivery device(s), and drawing the anchors together to tightenthe annulus. The devices include an elongate catheter with a housing ator near the distal end for releasably housing one or more anchors, aswell as guide devices for facilitating advancement and/or positioning ofan anchor delivery device. The devices may be positioned such that thehousing abuts or is close to valve annular tissue, such as the regionwithin the upper left ventricle bound by the left ventricular wall, amitral valve leaflet and chordae tendineae. Self-securing anchors havingany of a number of different configurations may be used in someembodiments.

In FIG. 1, a cross-sectional depiction of a heart H is shown with oneembodiment of a guide catheter 100 advanced in a retrograde directionthrough the aorta A and into the left ventricle LV. Retrograde, as usedherein, generally refers to a direction opposite the expected flow ofblood. This access route is used to reach the subvalvular space 106.Guide catheter 100 is generally a flexible elongate catheter which mayhave one or more curves or bends toward its distal end to facilitateplacement of the distal end 102 of the catheter 100 at the desiredlocation. The subvalvular space, as used herein, generally includes theportion of the ventricular chamber that is bound peripherally by theventricular wall, superiorly by the atrio-ventricular valve leaflets,and centrally by the primary chordae tendineae, and is located along thecircumference of the valve annulus. The subannular groove region, asused herein, includes the space bordered by the inner surface of theventricular wall, the inferior surface of valve leaflets L, and thethird order chordae tendineae CT connected directly to the ventricularwall VW and the leaflet L. The distal end 102 of guide catheter 100 maybe configured to be positioned at an opening into the subvalvular space106 or within the subvalvular space 106, such that subsequent deliverydevices may be passed through guide catheter 100 into the subvalvularspace 106. Although the retrograde aortic access route preferably startsfrom a percutaneous or peripheral access site, in some embodiments,aortic access may be achieved by an incision in the ascending aorta,descending aorta, aortic arch or iliac arteries, following surgical,thorascopic or laparoscopic access to a body cavity.

In other embodiments of the invention, other spaces bound by or relatingto one or more cardiac structures may be used as a target region of theheart. These structures include but are not limited to the base of theventricle, the mitral valve, the tricuspid valve, the primary chordaetendineae, the secondary chordae tendineae, the tertiary chordaetendineae, the anterior mitral valve leaflet chordae tendineae, theposterior mitral valve leaflet chordae tendineae, the interleafletchordae tendineae, the papillary muscle, the anterior-lateral papillarymuscle, the posterior-medial papillary muscle, the ventricular apicalregion, and the ventricular apex. For example, in some embodiments, asupra-apical space from about the base of the mitral valve leaflets tothe just above the ventricular apex or apical region may be the targetregion. In another example, the target region may be the peri-papillarymuscle region, which includes the space about 1 cm above and about 1 cmbelow the level of the papillary muscle region, as well as the spacesbetween the papillary muscles. In some examples, the target region maybe the endocardial surface abutting or accessible from the given spaceor cardiac structures. In still other embodiments, the target region maybe a region between the base and apex of a ventricle and betweenlongitudinal borders drawn through the papillary muscles, e.g. either aposterior-lateral or an anterior-medial ventricular endocardial surface.In other embodiments, the target region may exclude the space along thelongitudinal axis from the base of a ventricle to the apex of theventricle, e.g. the target region may be tubular or toroidal inconfiguration, with an internal border relating to a chordae tendineae.Other examples of target regions are depicted in FIGS. 19 and 20, andare discussed in greater detail below.

FIG. 2 provides a flowchart depiction of one method 120 for deploying atleast two anchors of the implant in the region of a heart valve annulus.As shown there, this illustrative method comprises advancing a guidecatheter to the subannular groove region 122, advancing a guidewirethrough a lumen of the guide catheter 124, advancing a guide tunnel ortunnel catheter over the guidewire 126, and proximally withdrawing theguidewire from the tunnel catheter 128. In this particular embodiment,the tunnel catheter comprises an outer catheter with a passageway inwhich an inner catheter slidably resides. After the guidewire has beenproximally withdrawn, a first delivery catheter may be advanced throughthe lumen of the tunnel catheter 130 and a first anchor may be deployedinto a first region of the heart valve annular tissue 132. The firstanchor is typically coupled or secured to a guide element, such as atether. In this way, after the first anchor is secured to heart tissue,the guide element will remain coupled to the first anchor. While theguide element may be used as a track or monorail for the advancement ofadditional delivery catheters thereover, the guide element is also acomponent of the implant that interconnects the multiple anchors. Aportion of the guide element facilitates the tightening of the implantand remains in the body with the anchors after the delivery system isremoved from the body.

The guide element may be made from any suitable or desirablebiocompatible material. The guide element may be braided or not braided,woven or not woven, reinforced or impregnated with additional materials,or may be made of a single material or a combination of materials. Forexample, the guide element may be made from (1) a suture material (e.g.,absorbable suture materials such as polyglycolic acid and polydioxanone,natural fibers such as silk, and artificial fibers such aspolypropylene, polyester, polyester impregnated withpolytetrafluoroethylene, nylon, polyetheretherketone, etc.), (2) a metal(absorbable or non-absorbable), (3) a metal alloy (e.g., stainlesssteel), (4) a shape memory material, such as a shape memory alloy (e.g.,a nickel titanium alloy), (5) other biocompatible material, or (6) anycombination thereof. In some variations, when pulled proximally whilerestraining the position of the proximal anchor, the guide element maybe used to cinch or reduce the circumference of the atrio-ventricularvalve annulus or the annular tissue. In certain variations, the guideelement may be in the form of a wire. The guide element may includemultiple layers, and/or may include one or more coatings. For example,the guide element may be in the form of a polymer-coated wire. Incertain variations, the guide element may consist of a combination ofone or more sutures and one or more wires. As an example, the guideelement may be formed of a suture that is braided with a wire. In somevariations, the guide element may be formed of one or more electrodematerials. In certain variations, the guide element may be formed of oneor more materials that provide for the telemetry of information (e.g.,regarding the condition of the target site).

In some embodiments, the guide element may include one or moretherapeutic agents (e.g., drugs, such as time-release drugs). As anexample, the guide element may be partially or entirely coated with oneor more therapeutic agents. In certain variations, the guide element maybe used to deliver one or more growth factors and/or geneticregenerative factors. In some variations, the guide element may becoated with a material (e.g., a polymer) that encapsulates or controlsthe release rate one or more therapeutic agents, or in which one or moretherapeutic agents are embedded. The therapeutic agents may be used, forexample, to treat the target site to which the guide element is fixedlyattached or otherwise secured. In certain variations, the guide elementmay include one or more lumens through which a therapeutic agent can bedelivered.

After the first anchor has been deployed in the region of the heartvalve annular tissue, the first delivery catheter is withdrawnproximally from the tunnel catheter. While maintaining the existingposition of the outer catheter of the tunnel catheter about thesubannular groove region, the inner catheter of the tunnel catheter isrepositioned at a second opening of the outer catheter 134. A seconddelivery catheter is then advanced over the guide element through thelumen of the tunnel catheter 136. In some embodiments, subsequentdelivery of anchors can be achieved by removing and reloading the firstdelivery catheter. In other embodiments, the delivery catheter is loadedwith a plurality of anchors and does not need to be withdrawn from thetunnel catheter to deliver subsequent anchors.

During advancement of the second delivery catheter over the guideelement, the guide element may enter the second delivery catheterthrough an opening at its distal end, and exit the second deliverycatheter through an opening in its side wall that is proximal to itsdistal end. Alternatively, the guide element may enter the seconddelivery catheter through an opening at its distal end, and exit thesecond delivery catheter through an opening at its proximal end, or atany other location proximal to the distal end. After the second deliverycatheter has been advanced over the guide element through the lumen ofthe tunnel catheter, a second anchor is deployed into a second region ofthe heart valve annular tissue using a second opening of the tunnelcatheter 138.

The procedure described above represents one embodiment of the inventionthat may be used to treat the annular tissue of the mitral valve. Inother embodiments of the invention, other tissues or structures of theheart and vasculature can also be treated, including but not limited tothe subvalvular apparatus, septal structures and the myocardium. Instill other embodiments, one or more cinchable implants may be deployedin non-cardiac tissues or structures, for example, to treatgastrointestinal disorders such as obesity, genitourinary conditionssuch as incontinence, or to perform cosmetic and reconstructiveprocedures.

FIGS. 3A to 3I provide a more detailed depiction of the method shown inflowchart form in FIG. 2. In FIGS. 3A to 3I, the mitral valve MV of FIG.1 is depicted schematically from an inferior perspective looking in asuperior direction, but in other embodiments of the invention thetricuspid valve, pulmonary valve or aortic valve may be accessed.Referring to FIG. 3A, a guide catheter 140 is advanced to subannulargroove region 104 using any of the access routes (or any other suitableaccess routes) described herein. In FIG. 3B, after guide catheter 140has been positioned at the desired location in subannular groove region104, a guidewire 144 is advanced through the lumen of guide catheter140. Guidewire 144 may be advanced beyond the distal end 146 of guidecatheter 140, so that guidewire 144 extends further along subannulargroove region 104 than guide catheter 140, as shown in FIG. 3B.

After guidewire 144 has been positioned in the subannular groove region104, a guide tunnel or tunnel catheter 148 is advanced through guidecatheter 140, over guidewire 144, as shown in FIG. 3C. Tunnel catheter148 may be any suitable catheter, and in some instances, it is desirablethat the tunnel catheter be pre-shaped or pre-formed at its distal end,such as the tunnel catheter illustrated in FIG. 3C. In some embodiments,tunnel catheter 148 may have a pre-shaped distal portion that is curved.In this way, the tunnel catheter may more easily conform to the geometryof the atrio-ventricular valve. It should also be understood that any ofthe catheters or guidewires described here may be pre-shaped orpre-formed to include any number of suitable curves, angles orconfigurations. Of course, the guidewires and/or catheters describedhere may also be steerable.

After tunnel catheter 148 has been positioned in the subannular grooveregion 104, guidewire 144 is withdrawn proximally as shown in FIG. 3D. Adelivery catheter (not shown) may then be advanced through the lumen oftunnel catheter 148 and toward opening 154 at or adjacent to the distaltip 156 of tunnel catheter 148. In the embodiment depicted in FIG. 3E,the delivery catheter remains within tunnel catheter 148, and anchor 158is deployed through opening 154 to attach to the body tissue. In otherembodiments, however, the delivery catheter may be extended throughopening 154 of tunnel catheter 148. Exemplary embodiments of a deliverycatheter are depicted and described in greater detail below.

In some embodiments of the invention, opening 154 is the distalmostanchor delivery opening of tunnel catheter 148, but in some embodiments,one or more openings may have a separate lumen in tunnel catheter 148,so that any anchors deployed from such openings would not interfere orrestrict the deployment of subsequent tissue anchors distal to thoseopenings. Furthermore, although FIG. 3E depicts opening 154 as a sideopening of tunnel catheter 148, in some embodiments, opening 154 may belocated at the distal tip 156 and may be the same opening shown with adistally protruding guidewire 144 in FIG. 3C.

Anchor 158, shown in FIG. 3E, is preferably a self-expanding design asit exits the delivery catheter and tunnel catheter 148 to self-secureinto the annular tissue accessible from the subannular groove region104. It should be understood that one or more anchors of an implant maybe deployed into the annulus directly, while other anchors may besecured to other tissue in the vicinity of the subannular groove region104. For example, one or more anchors may be secured to the tissue belowthe annulus. After anchor 158 has been deployed, the delivery cathetermay be proximally withdrawn. A tether 160, attached to anchor 158 andseen best in FIGS. 3G and 3H, may be used to facilitate the insertion ofadditional delivery catheters toward the implantation site.

In this particular embodiment, as demonstrated in FIG. 3F, tunnelcatheter 148 is maintained in the same position while additional anchors164 and 158′ are deployed from additional openings 164′ and 154′ alongtunnel catheter 148. In some embodiments, one or more delivery cathetersare serially inserted into tunnel catheter 148 using tether 160 toserially guide anchors 164 and 158′ through openings 164′ and 154′. Insome embodiments, the delivery catheters may be loaded with one or moreanchors at the point-of-use, while in other embodiments the deliverycatheters may be pre-loaded at the point-of-manufacture. In otherembodiments, the delivery catheters may be reloaded at the point-of-use,while in other embodiments, the delivery catheters are single-usedevices that are discarded after anchor deployment. In otherembodiments, the delivery catheters are configured to hold two or moreanchors 158, 158′ and 164 and can deliver multiple anchors withoutrequiring withdrawal of the delivery catheter between anchordeployments. Still other multi-anchor delivery catheters are configuredto deliver multiple anchors simultaneously through multiple openings oftunnel catheter 148. Anchors 158, 158′ and 164 may be deployed from thedelivery catheter and tunnel catheter 148 in any suitable fashion,including but not limited to a push-pull wire, using a plunger, or othersuitable actuation technique. Similarly, anchors 158, 158′ and 164 maybe coupled to tether 160 by any suitable attachment method. For example,one or more knots, welded regions, and/or adhesives may be used.Alternate embodiments for anchor deployment and anchor attachments aredescribed in U.S. patent application Ser. No. 11/583,627, which ishereby incorporated by reference in its entirety.

“Anchors,” for the purposes of this application, are defined to mean anyfasteners. Thus, the anchors may comprise C-shaped or semicircularhooks, curved hooks of other shapes, straight hooks, barbed hooks, clipsof any kind, T-tags, or any other suitable fastener(s). In oneembodiment, anchors may comprise two tips that curve in oppositedirections upon deployment, forming two intersecting semi-circles,circles, ovals, helices or the like. In some embodiments, the tips maybe sharpened or beveled. In some embodiments, the anchors areself-deforming. By “self-deforming” it is meant that the anchors arebiased to change from a first undeployed shape to a second deployedshape upon release of the anchors 210 from a restraint. Suchself-deforming anchors may change shape as they are released from ahousing or deployed from a lumen or opening to enter annular tissue, andsecure themselves to the tissue. Self-deforming anchors may be made ofany suitable material such as spring stainless steel, or super-elasticor shape-memory material like nickel-titanium alloy (e.g., Nitinol).

In other embodiments, the anchors may be made of a elastic material andmay be loaded into a delivery catheter in such a way that they changeshape upon release. For example, anchors that are not self-deforming maybe secured to tissue via crimping, firing or other application ofmechanical force to facilitate tissue penetration and/or securement.Even self-securing anchors may be crimped in some embodiments of theinvention, to provide enhanced attachment to tissue. In someembodiments, anchors may comprise one or more bioactive agents,including biodegradable metals and, polymers. In another embodiment, theanchors may comprise electrode components. Such electrodes, for example,may sense various parameters including but not limited to impedance,temperature and electrical signals. In other embodiments, suchelectrodes may be used to supply energy to tissue at ablation orsub-ablation amounts.

FIG. 4A, for example, depicts an implant comprising multipleself-expanding, non-plicating anchors 166 deployed in the subannulargroove region 104. FIG. 4B depicts an implant comprising multiple T-taganchors 168 deployed in the subannular groove region 104, and FIG. 4Cdepicts transmural anchors 170 inserted from the coronary sinus 172 andinto the subannular groove region 104. Other anchors may comprisefibrous or porous materials in the shape of bars, rods or pledgets. Insome instances, the fibrous or porous materials may expand in volume.Additionally, while the delivery and deployment of multiple anchors ofthe same shape over a single guide element have been described, in somevariations, a single guide element can be used to deliver and deploymultiple anchors having different shapes or non-uniform implantationsites. Similarly, in certain embodiments, a single guide element can beused in the delivery and deployment of multiple anchors having differentsizes. Illustrative examples of suitable anchors are described in moredetail, for example, in U.S. patent application Ser. No. 11/202,474,which is hereby incorporated by reference in its entirety.

In the embodiments depicted in FIGS. 3A to 3I, before a second deliverycatheter is advanced through tunnel catheter 148, tether 160 is threadedinto the delivery catheter, and is slidably engaged with a second anchor164. In some embodiments, second anchor 164 is preloaded into the seconddelivery catheter before threading to tether 160, while in otherembodiments, the second anchor is pre-threaded before being loaded intothe second delivery catheter. Any of a number of different methods canbe used to thread a guide element, such as tether 160, into a deliverycatheter, and to engage the guide element with an anchor. Other methodsare disclosed in U.S. patent application Ser. No. 11/202,474, which waspreviously incorporated by reference, and threading devices aredescribed, for example, in U.S. patent application Ser. No. 11/232,190,which is hereby incorporated by reference in its entirety.

With reference to FIG. 3G, after all of anchors 158, 158′ and 164 havebeen deployed into body tissue, tunnel catheter 148 is withdrawn fromguide catheter 140. The separation of the tunnel catheter 148 from theanchors 158, 158′ and 164 may occur by any of a variety of mechanisms,examples of which are described in greater detail below. In FIG. 3H, atermination catheter 174 is inserted through guide catheter 140 overtether 160. Termination catheter 174 is used to facilitate tensioning oftether 160, thereby cinching anchors 158, 158′ and 164 together toremodel the annular tissue and to secure the cinched anchors 158, 158′and 164 with a termination member 176 that resists tether loosening orslippage, as illustrated in FIG. 3I. In other embodiments, terminationcatheter 174 can secure tether 160 to an anchor or to body tissuewithout the use of termination member 176. Devices and methods forperforming termination of cinchable implants are described in U.S.patent Ser. No. 11/232,190, which was previously incorporated byreference.

The catheters described herein, including tunnel catheter 148, may beformed of any of a number of different materials. Examples of suitablematerials include polymers, such as polyether-block co-polyamidepolymers, copolyester elastomers, thermoset polymers, polyolefins (e.g.,polypropylene or polyethylene, including high-density polyethylene andlow-density polyethylene), polytetrafluoroethylene, ethylene vinylacetate, polyamides, polyimides, polyurethanes, polyvinyl chloride (PVC,fluoropolymers (e.g., fluorinated ethylene propylene, perfluoroalkoxy(PFA) polymer, polyvinylidenefluoride, etc.), polyetheretherketones(PEEKs), and silicones. Examples of polyamides include Nylon 6 (e.g.,Zytel® HTN high performance polyamides from DuPont™), Nylon 11 (e.g.,Rilsan® B polyamides from Arkema Inc.), and Nylon 12 (e.g., Grilamid®polyamides from EMS-Grivory, Rilsan® A polyamides from Arkema Inc., andVestamid® polyamides from Degussa Corp.). In some variations, tunnelcatheter 148 may be formed of multiple polymers. For example, a cathetermay be formed of a blend of different polymers, such as a blend ofhigh-density polyethylene and low-density polyethylene. While the wallof a catheter may be formed of a single layer, some variations ofcatheters may include walls having multiple layers (e.g., two layers,three layers). Furthermore, some variations of catheters may include atleast two sections that are formed of different materials and/or thatinclude different numbers of layers. Additionally, certain variations ofcatheters may include multiple (e.g., two, three) lumens. The lumens orwalls may, for example, be lined and/or reinforced (e.g., with braidingor winding). The reinforcing structures, if any, may be metallic orcomprise a non-metal or polymer having a higher durometer.

As illustrated in FIG. 5A, in one embodiment of the invention, distalportion 102 of delivery device 100 is positioned in a desired locationunder a valve leaflet L and adjacent a ventricular wall VW. The valveannulus VA generally comprises an area of heart wall tissue at thejunction of the ventricular wall VW and the atrial wall AW that isrelatively fibrous and, thus, significantly stronger than leaflet tissueand other heart wall tissue. It is noted, however, that considerablestructural variations of the annulus exist within patient populationsand that attempted delivery of an implant to the valve annulus VA mayinstead contact or attach to the tissue adjacent to the valve annulus.The term “annular tissue” as used herein shall include the valve annulusand the tissue adjacent or surrounding the valve annulus.

Distal portion 102 of guide catheter 100 may be advanced into positiongenerally under the valve annulus VA by any suitable technique, some ofwhich are described below. Distal portion 102 of guide catheter 100 maybe used to deliver anchors to the valve annular tissue, to stabilizeand/or expose the annulus, or both. In one embodiment of the invention,using guide catheter 100 having a flexible elongate body as shown inFIG. 1, flexible distal portion 102 may be positioned in the leftventricle LV at the level of the mitral valve leaflets MVL using any ofa variety of access routes described herein. Distal portion 102 may beadvanced under the posterior valve leaflet into a space such as thesubannular groove region 104 or in the subvalvular space 106. Referringback to FIG. 5A, It has been found that when guide catheter 100 ispassed, for example, under the mitral valve via an intravascularapproach, guide catheter 100 may be inserted into the subannular grooveregion 104 or the subvalvular space 106 and advanced either partially orcompletely around the circumference of the valve. Once in subannulargroove region 104 or the subvalvular space 106, distal portion 102 ofguide catheter 100 may be positioned proximate to the intersection ofthe valve leaflet(s) and the ventricular wall VW, which is near thevalve annulus VA. These are but examples of possible access routes of ananchor delivery device to a valve annulus, and any other access routesmay be used. In other embodiments, guide catheters such as thosedescribed in U.S. Pat. No. 6,203,531, may be used. U.S. Pat. No.6,203,531 is herein incorporated by reference in its entirety.

In some embodiments, it may be advantageous to provide guide catheter100 with a curvable portion with a radius in an expanded/curved statethat is greater than a radius of the valve annulus, the subannulargroove region or ventricular chamber. The relative size of this portionof guide catheter 100, when positioned within the smaller sizedventricle, may exert a radially outward force that can improve thesurface contact between guide catheter 100 and the left ventricle LV.For example, in one embodiment, guide catheter 100 in the expanded statehas a radius about 25% to about 50% larger that the valve annulus.

In addition to delivering anchors to the annular tissue, the guidecatheter 100 (and specifically distal portion 102) may be used tostabilize and/or expose the valve annulus or annular tissue. Suchstabilization and exposure are described fully in U.S. patentapplication Ser. No. 10/656,797, which is incorporated by reference inits entirety. For example, once the distal portion 102 is positionedgenerally under the annular tissue, force may be applied to the distalportion 102 to stabilize the valve annulus VA or annular tissue, asshown in FIG. 5B. Such force may be directed in any suitable directionto expose, position and/or stabilize the annulus or annular tissue. Inanother example, an upward and lateral force is shown in FIG. 5B by thesolid-headed arrow drawn from the center of the distal portion 102. Inother examples, only upward, only lateral, or any other suitableforce(s) may be applied. With application of force to the distal portion102, the annular tissue may rise or project outwardly, thus exposing theannulus for easier viewing or access. The applied force may alsostabilize the valve annulus VA or valve annular tissue, alsofacilitating surgical procedures and visualization.

In some embodiments, additional force may be exerted by the deliverydevice after the first anchor is engaged to body tissue. The firstanchor may provide additional leverage and stability for manipulatingthe delivery device(s). Referring to FIGS. 5C and 5D, a delivery device108 is schematically shown delivering an anchor 110 to a valve annulusVA or annular tissue. Embodiments of anchor delivery device 108 aredescribed in greater detail below. Anchor 110 is shown first housedwithin delivery device 108 in FIG. 5C and then delivered to the annulusVA or annular tissue, as depicted in FIG. 5D. Of course, although thedelivery and position of the anchor 110 is described with respect to thevalve annulus VA, one or more anchors 110 may miss the valve annulus VAand attach to other structures or tissues accessible from the subannulargroove region 104 (or subvalvular space 106).

As is shown, in some embodiments, anchors 110 may have a relativelystraight configuration when housed in delivery device 108, with twopenetrating tips and a loop in between the tips. Upon deployment fromdelivery device 108, the tips of anchor 110 may curve in oppositedirections to form two semi-circles, circles, ovals, overlapping helicesor the like. This is but one example of a type of self-securing anchorwhich may be delivered to an annular tissue. Additional anchorembodiments are described below, and may also be found in U.S. patentapplication Ser. No. 11/202,474, which was previously incorporated byreference. Multiple coupled anchors 110 may be delivered, and theanchors 110 are drawn together to tighten the valve annulus.

Although delivery device 108 is shown having a circular cross-sectionalshape in FIGS. 5C and 5D, it may alternatively have any other suitableshape. In one embodiment, for example, it may be advantageous to providea delivery device having an ovoid or elliptical cross-sectional shape.Such a shape may help ensure that the device is aligned, when positionedbetween a corner formed by a ventricular wall and a valve leaflet, suchthat one or more openings in the delivery device is oriented to deliverthe anchors in their desired orientation into valve annulus tissue. Tofurther enhance contacting of the annular tissue and/or orientation ofthe delivery device, some embodiments may further include an expandablemember, coupled with the delivery device, which expands to urge or pressor wedge the delivery device into the corner formed by the ventriclewall and the leaflet to contact the valve annulus. Such enhancements aredescribed further below.

In several embodiments of the invention, one or more self-forminganchors 900 are stored in the delivery device in a straightenedconfiguration, coupled with a tether 902, as shown in FIG. 6A. Anchors900 are held or restrained in that straightened state, while theirdeployed configuration is non-linear or curved. Arms 901 meet at ajunction section 903, which is slidably coupled to the tether 902. Insome embodiments, junction section 903 comprises an open or closed loopconfiguration and may change in size or configuration when arms 901 aredeployed. In this particular embodiment, as arms 901 of anchor 900 arereleased from the delivery system, arms 901 are permitted to resumetheir deployed configuration, penetrating the tissue T along apenetration pathway. As the distal portions of arms 901 regain theirdeployed configurations, arms 901 will separate and reorient toward thetissue surface (as depicted as open-headed arrows). In some embodiments,the penetration pathways are curved so that as anchor 900 furtherpenetrates into tissue T, junctional section 903 of anchor 900 willcontinue along a similar pathway as the arms 901. This may reduce thedegree of tissue compression or stretching as anchor 900 is deployed,which in turn may also reduce any resulting arrythmogenic risk, if any,from anchor deployment. The horizontal and vertical forces generated(depicted as open arrows) by arms 901 may also result in a counterforcewhich causes junction section 903 to be brought toward the tissuesurface (down open arrows) and may even pull portions of junctionsection 903 into tissue T, as shown in FIG. 6B. Once the anchor is fullydeployed, as in FIG. 6C, anchor 900 may be substantially embedded in thetissue T.

Portions of tether 902 coupled to junction section 903 are also broughtcloser to the surface of tissue T. Bringing tether 902 closer to tissueT may be beneficial because a greater proportion of the cross-sectionalblood flow path, as bordered by tether 902, is preserved, which mayreduce the risk that any subsequent catheters or implanted componentsinserted into the heart chamber or valve will snag or damage tether 902.Also, it may reduce the degree of hemolysis compared to a tether thatcrosses the mitral flow pathway farther from the tissue surface. Variousanchor designs and deployment methods are disclosed, for example, inU.S. patent application Ser. Nos. 10/741,130, 10/792,681, 10/900,980,11/255,400, and 10/901,555, which are herein incorporated by referencein their entirety, as well as U.S. patent application Ser. No.11/202,474, previously incorporated by reference.

Referring now to FIGS. 7A through 7E, in one embodiment of theinvention, the guide tunnel 700 comprises a tubular body 702 with acentral passageway 703 and multiple openings 704. Central passageway703, depicted in FIGS. 7D and 7E, permits the insertion of a deliverycatheter and the alignment of one or more retained anchors with one ormore of the openings 704 of guide tunnel 700. Typically, openings 704are grouped in a distal portion 706 of guide tunnel 700, but in otherembodiments, openings 704 may be located more proximally. The lengthsand configurations of the tubular body 702 and distal portion 706 mayvary depending upon a variety of factors, including but not limited tothe desired target location, such as the subannular groove region, andthe access route, whether it is retrograde, antegrade, or requires atransseptal puncture. In one example, distal portion 706 of guide tunnel700 comprises a flexible curved configuration. In some embodiments,openings 704 are preferably aligned along the greater curvature 708 ofdistal portion 706. In other embodiments, openings 704 may be alignedalong the superior junction of the curved distal portion. Similarly,guide tunnel 700 may be configured for a cinchable implant inserted viathe coronary sinus by aligning openings 704 along the lesser curvature710 of distal portion 706. Distal portion 706 may optionally comprise anatraumatic tip, such as an inflatable balloon or a tapered tip 709comprising a material with a low durometer. Guide tunnel 700 may be usedin conjunction with a guide catheter to facilitate positioning of adelivery catheter at the desired anchoring sites.

In some embodiments, the openings 704 are arranged in a linearconfiguration along a longitudinal length of guide tunnel 700. Althoughopenings 704 are depicted in FIG. 7A through 7E as having uniformdimensions, shapes, uniform spacing and angular and linear alignment,these and other features of guide tunnel 700 may be varied as desired.For example, if the cinchable implant comprises anchors of differentsizes and anchor spacings, the anchor opening cross-sectional shapes andareas and relative spacing may be designed accordingly. For example,opening 704 of guide tunnel 700 has a generally semi-cylindrical shape(or rectangular shape when opening 704 is viewed orthogonally), whilethe aperture 528 of delivery device 520 in FIGS. 12A and 12B aregenerally oval in shape. In other examples, the openings of the guidetunnel may be squared, circular, semi-circular, triangular, octagonal,rhomboidal, trapezoidal, crescent-shaped, or any other shape. In stillother examples, the openings may comprise slits which may deform toallow passage of an anchor or other component. The slits may have any ofa variety of configurations, including linear, arcuate, cross orstar-shaped configurations, for example.

FIG. 24 depicts an example of a guide tunnel 900 comprising multipleapertures 902, 904 with a non-rectangular shapes. The longitudinallyorigented edges 906 and 908 of each aperture 902 and 904 are configuredso that they form a non-perpendicular angle with respect to thetransverse edges 910, 912 and 914 of the retention elements 916 and 918,and the transverse edge 920 of the distal section 922 of the guidetunnel 900. As depicted, the longitudinal edge 906 of aperture 902comprises angled sections 906 a and 906 b adjacent to the retentionelements 916 and 918 which are angled toward the base 924 and 926 of theretention elements 916 and 918, forming acute angles 928 and 930. Theangle between the angled sections of the longitudinal edges and theretention elements may be uniform or non-uniform with respect to eachother and the edges may comprise straight, curved or other non-linearsections. The angles 928 and 930 may be in the range of about 0 degreesto about 180 degrees, in some configurations about 5 degrees to about 85degrees, in other configurations about 10 degrees to about 45 degrees,and still other configurations about 20 degrees to about 30 degrees,while some alternate configurations is in the range of about 90 degreesto about 135 degrees, or about 100 degrees to about 120 degrees. Thelongitudinal edge 908 of aperture 904, for example, comprises a distalsegment 908 b is at a 110 degree angle with respect to the transverseedge 920 of the distal section 922 of the guide tunnel. In someexamples, an obtuse angle between a longitudinal edge and a transverseedge of the guide tunnel may reduce the risk of an edge catching orinterfering with adjacent anatomical structures and/or other devices orinstruments inserted into the guide tunnel. However, obtuse angles arenot limited to the distalmost apertures, or to the distal section of anaperture. The longitudinal dimensions of the non-orthogonal sections 906a, 906 b and 908 b may each in the range of about 5% to about 50% of thetotal longitudinal dimension of the generally longitudinal edges,sometimes about 5% to about 25%, and other times about 10% to about 20%.

Guide tunnel 700 may be used in beating heart procedures where it isdifficult to control the position of the distal end of a deliverycatheter with respect to the target tissue. By providing multipleopenings 704, once guide tunnel 700 has been positioned at its desiredlocation, it need not be moved to deploy a plurality of anchors.Instead, the delivery catheter can be manipulated within the non-movingguide tunnel 700 to deploy the anchors through the provided openings704. Thus, guide tunnel 700 may reduce the risk that during a lengthyprocedure with multiple anchoring sites, repositioning of the deliverycatheter to a new target location may dislodge the delivery catheterfrom hard-to-reach target sites that are easily lost. In addition totransluminal procedures, guide tunnel 700 may also be used with open orlimited access surgeries. In further embodiments of the invention, guidetunnel 700 may be configured with a shorter longitudinal length and/or amore rigid body for some surgical applications.

During the deployment of a cinchable implant, when the anchors have beensecured to their target sites, the coupling members or one or moresegments of the tether may still be looped within the delivery catheteror guide tunnel 700. This may be beneficial when implanting anchors inunstable body regions such as a beating heart because with eachdeployment of an anchor, the retention of a tether segment in guidetunnel 700 further secures guide tunnel 700 to the sites where theanchors have been secured. Once all of the anchors have been deployed,however, the retained tether segments will need to be separated fromguide tunnel 700 so that guide tunnel 700 may be withdrawn.

In one embodiment of the invention, the retaining structures betweenanchor openings 704 may be configured to releasably retain the tether orcoupling elements between the anchors. In a further embodiment, depictedin greater detail in FIGS. 14A through 14H, the retaining structurescomprise latch structures 712 located between two adjacent openings 704of guide tunnel 700. Referring back to FIG. 7B, which depicts latches712 of guide tunnel 700 pulled away from tubular body 702, in someembodiments, latch 712 may comprise a base 714 and a free end 716. Insome embodiments, latch 712 comprises a material and/or configuration topermit some deformation or deflection of latch 712 and for a tether orcoupling member retained between two adjacent openings 704 to pass outof guide tunnel 700. Thus, in some embodiments, latch 712 comprises aflexible material, but in other embodiments, one or more latches maycomprise a rigid material with a hinge joint or other type of joint thatpermits latch movement. The edges or corners of the latch structures 712and/or openings 704 may be angled, as depicted in FIG. 14, or may berounded.

Referring to FIG. 14B, latch 712 may be configured to permit control ofthe retention and/or release of the tether between deployed anchors. Insome embodiments, latch 712 comprises a lumen 718 that is alignable withcomplementary segments 720 of a lumen located in the wall of the tubularbody 702. The complementary lumen segments 720 may be provided in anotched region 724 which is complementary to free end 716 of latch 712.When aligned, each adjacent lumen 718 and segment of the longitudinallumen 720 permits the insertion of a locking element 722. Lockingelement 722 can releasably secure the latch 712 in the notched region724 by maintaining the alignment between the lumen 718 of latch 712 andlumen segment 720 of tubular body 702, thereby restricting the passageof a coupling member. When anchors are deployed through openings 704adjacent to latch 712, the tether will be retained by latch 712.

In some embodiments, locking element 722 may have an elongateconfiguration and comprise a wire thread, or ribbon formed from metal,polymer, or combination thereof. Referring back to the embodimentdepicted in FIG. 7A, latch 712 comprise transverse through-lumens 718that complement the lumen segments of the longitudinal lumen 720 of thetubular body 702, but the particular orientations of the lumens orlocking elements may vary, depending on the desired orientation ofopenings 704. Lumen 718 of latch 712 need not be a through-lumen or atransversely oriented lumen with respect to base 714 and free end 716 oflatch 712. In some embodiments, latches 712 may comprise radio-opaquematerial to facilitate the positioning of a delivery catheter withrespect to guide tunnel 700. In other embodiments, radio-opaque materialmay be located in or on tubular body 702 in angular position generallyopposite one or more latches 712 or elsewhere.

In some embodiments, latch 712 may not maintain the alignment of lumen718 with its complementary lumens 720 once locking element 722 isremoved. In these embodiments, reinsertion or rethreading of lockingelement 722 back into lumen 718 may not work in situ. In otherembodiments, however, guide tunnel 700 may be constructed such thatlatch 712 is biased to an alignment position and locking element 722 maybe reengaged to one or more lumens 718, 720. To facilitate initialinsertion or reinsertion of locking element 722 into lumens 718, 720,lumens 718, 720 may be provided with one or more tapered lumen openings760 as depicted in FIG. 8F.

In some embodiments, a single locking element 722 is provided and isinsertable through all lumens 718 of latch 712 and complementary lumens720 of tubular body 702, and the aggregate lumen path from lumens 718and complementary lumens 720 is substantially linear or curvilinear.With these particular embodiments, release of latches 712 start with thedistalmost latch and finish with the most proximal latch. In otherembodiments, the lumens and the locking element, such as the lockingelement 725 shown in FIG. 9B, may be configured to simultaneouslyrelease two or more latches 712. With locking element 725, branchedsegments 726 of locking element 725 permit parallel release of latches712.

Although FIG. 14B depicts an interlocking fit between locking element722, lumen 718 and lumen segment 720, other retaining mechanisms mayalso be used. In FIG. 22A, for example, a guide tunnel 300 with aplurality of delivery catheter apertures 302 is provided. Deliverycatheter apertures 302 are separated by retaining members 304 with anopen seam or gap 306. As shown schematically in FIG. 22B, after anchordeployment is completed, guide tunnel 300 may be rotated or otherwisemoved away from the retained tethers 308 to permit release of tether 308from guide tunnel 300 through gaps 306. Guide tunnel 300 can then beseparated from the tethered anchors 310.

FIG. 23A depicts another embodiment of a guide tunnel 312, comprising anouter guide 314 with one or more openings 316, each configured todeliver a plurality of anchors at along a range a length, and an innerguide within outer guide 314 comprising a tubular body with two or morelongitudinally spaced retaining members 316. Retaining members 316 maybe configured for release with one or more locking elements, or may beconfigured for displacement from a retained tether similar to theconfiguration of retaining members illustrated in FIG. 22A.

FIGS. 7A to 7D illustrate an embodiment comprising latches 712 with agenerally symmetrical protruding structure that lacks sharp corners.FIGS. 8A through 8D depict other embodiments of the invention withlatches of different configurations. In FIG. 8A, for example, the latch762 is generally symmetrical with a larger base and squared edges. InFIG. 8B, latch 864 is also generally symmetrical with a larger base butwith rounded edges. In FIGS. 8C and 8D, though, latches 866 and 868,respectively are asymmetrical. Asymmetrical configurations may be usefulfor facilitating separation of an implant from the guide tunnel byangulating any force exerted on the latch edge toward the free end ofthe latch.

In other embodiments of the invention, locking element 722 may comprisean electrically conductive material that melts upon the application ofsufficient electrical current to permit the release of latch 712. Instill other embodiments, the releasable retaining mechanism may comprisemagnetic controlled locks or electropolymers embedded in latch 712 thatmay be controlled with application of current to wires embedded intubular body 702 between latches 712 and the proximal end of guidetunnel 700.

Referring back to FIG. 7A, proximally, guide tunnel 700 may comprise oneor more access ports. One or more of the ports 728, for example, mayalso be configured with a hemostatic seal to reduce blood loss duringthe procedure, and or with a reversible locking mechanism 730 tomaintain the relative position between an inserted component and guidetunnel 700. Port 728 may be used for insertion and removal of thedelivery catheter, for example. In some embodiments, one or more ports732, 734 may be provided to obtain blood samples, for injection ofradiographic or therapeutic agents, or for the attachment of a pressuretransducer. Another port 736 may be provided for manipulation of lockingelement 722 which controls the release of latch structures 712.

The hemostatic seal may comprise any of a variety of configurationsknown in the art. In some examples, the hemostatic seal may comprise oneor more slits on a septum or sealing member which forms one or more sealflaps. Upon insertion of an instrument or device through the sealingmember, the seal flaps deform or deflect to permit passage of the devicewhile exerting force around a perimeter of the device to substantiallyresist passage of fluid or gas through the sealing member. Referring toFIGS. 25A to 25C, in some examples, the sealing member 950 has a sealopening 952 comprising at least one non-linear slit 954 a-d with respectto the seal face 956 or a transverse plane of the seal axis 958. In thedepicted example, the sealing opening 952 comprises four arcuate orspiral-shaped slits 954 a-d arranged about the seal axis 958. Each ofthe slits 954 a-d has the same relative shape and size as the otherslits 954 a-d and uniformly spaced around the axis 958, but in otherexamples, a different number of slits may be provided, one or more slitsmay have a different size or shape, the slits may be non-uniformlyspaced or non-symmetrically arranged, and/or may intersect at locationdifferent from the center of the seal face 956. In FIG. 26, for example,the sealing member 980 comprises a plurality of multi-angled slits 982a-d.

Referring back to FIGS. 25A to 25C, the slits 954 a-d may have agenerally orthogonal orientation through the seal face 956, or may beangled or skewed. In some examples, the slits 954 a-d may be generallyangled with respect to the seal face 956 in the range of about 5 degreesto about 85 degrees, in some configurations about 10 degrees to about 60degrees, and in other configurations about 20 degrees to about 45degrees. The seal face 956 or seal member 950 may comprise any of avariety of elastic or flexible materials, including any of a variety ofsilicones such as NuSil Med-4035, Med-4820, and MED50-5338, may have adurometer in the range of about 20 to about 80, in some examples about15 to about 60, and in other examples about 20 to about 40. Thethickness 960 of the seal face 956 may be in the range of about 0.01″ toabout 0.1″, in some examples about 0.02″ to about 0.05″, and in otherexamples about 0.025″ to about 0.03″. As illustrated in FIG. 25B, theseal face 956 may be raised or offset from the body 962 of the sealingmember 950. The raised distance 964 of the raised seal face 956 may bein the range of about 0.01″ to about 0.2″, in some configurations about0.02″ to about 0.1″ and in other configurations about 0.04″ to about0.06″.

The body 962 comprises a lumen 966 in communication with the sealingopening 952. The lumen 966 may have a uniform or non-uniform diameter,cross-sectional area and/or cross-sectional shape. Lumens withnon-uniform diameters may taper toward or away from the seal opening952, and the taper may be linear or non-linear. In some examples, thelumen 966 may have an average diameter 968 in the range of about 0.05″to about 0.5″ or more, in some configurations about 0.1″ to about 0.3″,and in other configurations about 0.15″ to about 0.2″. The lumen 966 mayhave a length 970 anywhere in the range of about 0.1″ to about 1″ ormore, in some configuration about 0.2″ to about 0.5″, and in otherconfigurations about 0.25″ to about 0.4″. The body 962 may have any of avariety of shapes, including cylindrical, frustoconical, box-like orother shapes, and may be coupled to the guide tunnel by a frame orhousing.

In some embodiments, guide tunnel 700 may be used in conjunction with adelivery catheter comprising multiple anchors with preset spacing,similar to that depicted in FIGS. 12A and 12B. In further embodiments,the spacing of the delivery catheter may match the spacing of openings704 of guide tunnel 700. This particular combination may permitsimultaneous deployment of anchors or reduce the time spent to align thedelivery catheter and guide tunnel 700. In a preferred embodiment, adelivery catheter with plural anchors and a guide tunnel with pluralopenings may be provided in a kit with one or more other componentsdescribed herein.

In another embodiment, guide tunnel 700 further comprises an inner guidetunnel 750 that is reversibly insertable into passageway 703 of guidetunnel 700. In these and other embodiments comprising inner guide tunnel750, port 728 that is configured to receive the delivery catheter willbe located on the inner guide tunnel 750 while guide tunnel 700 willhave a port 752 configured to receive the inner guide tunnel 750. Innerguide tunnel 750 further comprises an inner tubular body 754 with one ormore openings 756 located at the distal end 758 of the inner tubularbody 754. Opening 756 may be configured with flanking or otherconfiguration of radio-opaque markers that can be used to align opening756 of inner guide tunnel 750 with the corresponding radio-opaquemarkers of latches 712. Opening 756 may comprise the same material asinner tubular body 754. In other embodiments, opening 756 is reinforcedwith a frame 806. In some embodiments, frame 806 may comprise a polymerof higher durometer than material comprising inner tubular body 754. Inother embodiments, frame 806 may comprise a metal such as stainlesssteel, cobalt chromium, platinum-iridium, or Nitinol. In furtherembodiments, frame 806 may be plated with an additional metal, includingbut not limited to gold. In some embodiments, frame 806 is plated withadditional material to alter its radio-opacity. Inner guide tunnel 750may also be configured with one or other proximal ports 734 previouslymentioned.

In some embodiments of the invention, guide tunnel 700, inner guidetunnel 750 or the delivery catheter may include a position sensor systemto detect the relative position of inner guide tunnel 750 and/or thedelivery catheter. In one embodiment, the position sensor systemcomprises a series of electrical contact points along passageway 703 ofguide tunnel 700 that can form an electrical circuit with one or moreelectrical contact points located on inner tubular body 754. Similarly,electrical contact points in the lumen of inner guide tunnel 750 can beused to detect the position of delivery catheters inserted therein. Theposition sensor system may be used as a substitute or in conjunctionwith radio-opaque markers to facilitate alignment of various components.Other types of position sensor system are also contemplated, includingbut not limited to optical and magnetic detection mechanisms.

In some embodiments of the invention, guide tunnel 700 with inner guidetunnel 750 may be used with delivery catheters comprising a singleanchor, or delivery catheters with multiple anchors. In theseembodiments, inner guide tunnel 750 may be used to simplify positioningof delivery catheters with respect to openings 704 on guide catheter700. Inner guide tunnel 750 may also be provided with one or more visualmarkings, detents, servo motor controlled positioning or othermechanisms to facilitate anchor delivery through openings 704. In someembodiments, inner guide tunnel 750 may be configured, for example, toreorient end-firing anchor delivery catheters to deploy anchors throughthe side openings 705 of guide tunnel 700.

In some embodiments, guide tunnel 700 and inner guide tunnel 750 may beconfigured to restrict or limit any rotational movement between the twocomponents. Such a feature may be useful when positioning in moredifficult target locations in the body that require considerable length,angulation and torque to reach that may result in rotation and/or lengthmisalignment. In one embodiment of the invention, depicted in FIGS. 14Cto 14E, passageway 703 of distal section 706 is configured with a rail800, groove or other alignment structure to resist rotational movementof inner guide tunnel 750. Rail 800 is attached at a distal end 804 anda proximal end (not shown) and permits inner guide tunnel 750 tolongitudinally slide along between its two attachment points, where rail800 passes through slots 802 or slits formed in the tubular body 754 ofinner guide tunnel 750. In some embodiments, the rail has a width tothickness ratio of about 5:1 to about 20:1, preferably about 8:1 toabout 16:1, and most preferably about 9:1 to about 14:1. In otherembodiments, rail 800 is not attached proximally and permits inner guidetunnel 750 to be fully withdrawn from guide tunnel 700 and exchanged fora different inner guide tunnel 750. Rail 800 preferably comprisesmaterials selected to reduce or minimize any friction or cohesioneffects between the rail and the material comprising tubular body 754 ofinner guide tunnel 750. In some embodiments, rail 800 may comprise ametal such as stainless steel or Nitinol. In other embodiments, rail 800or other alignment configuration may comprise a lubricious coating suchas PTFE to reduce movement resistance of inner guide tunnel 750. Instill other embodiments of the invention, rail 800 may have a differentcross sectional shape from flat band configuration depicted in FIG. 14C,including but not limited to square, rectangle, circle, oval or othergeometric shape.

In the embodiments of the cinchable implants described above, severalembodiments of guide tunnel 700 or tunnel catheter 148 depict a single,longitudinal arrangement of alternating identical sized openings 154 andidentical retaining elements or latches 712, but alternateconfigurations are also contemplated. These alternate configurations mayinclude, for example, two or more distinct groups, 768, 770, 772 ofopenings and retaining elements as illustrated in FIG. 10A, that mayinvolve single or multiple locking mechanisms that may be released inparallel, in serial or in a mixed fashion. FIG. 10B is anotherembodiment of a guide tunnel 774 comprising variable-sized openings 776,778 or retaining elements 780, 782, 784 and/or non-alternating retainingelements 780, 782, 784. The configuration depicted in FIG. 10B alsodemonstrates other features that may be incorporated into the tunnelcatheter 148. For example, certain materials used to provide adequatecolumn strength and torqueability to tunnel catheter 154 may result inretaining elements that are too stiff or bulky to easily release thetether safely. In some examples, the spacing between openings is suchthat the width of the retaining element is greater than the length ofthe retaining element by about 1×, or about 2× or about 3× multiple ormore. To reduce the potential of snagging or inability to pass thetether, a series of consecutive retaining elements 780, 782, 784 havinga smaller width may be used. FIG. 10B also depicts retaining elements786 with a tapered base 788 to facilitate bending of retaining elements786.

Referring again to FIGS. 14A through 14H, a more detailed description ofguide tunnel 700 is provided. FIG. 14A illustrates distal section 706 ofguide tunnel 700. Distal section 706 is configured with a curvatureconfigured to facilitate the placement of anchors in the subannulargroove region. Seven openings 706 are provided along the greatercurvature 708 of distal section 706. In other embodiments, the number ofopenings 706 may vary from about 2 or about 3, to about 30 or more. Inpreferred embodiments, openings 706 may number from about 5 to about 20,while in most preferred embodiments, openings 706 may number from about7 to about 10. In some embodiments, openings 706 may have a length ofabout 3 mm to about 20 mm, preferably about 5 mm to 10 mm and mostpreferably about 7 mm to about 8 mm. In some embodiments, openings 706may have a width of about 1 mm to about 10 mm, preferably about 2 mm toabout 7 mm, and most preferably about 3 mm to about 5 mm.

With reference now to FIG. 11, one embodiment of the invention comprisesan anchor delivery device 200, which suitably includes an elongate shaft204 having a distal portion 202 configured to deliver a plurality ofanchors 210, coupled with a tether 212, and configured for attachment toannular tissue. The tethered anchors 210 are housed within a housing 206of the distal portion 202, along with one or more anchor retainingmandrels 214 and a delivery opening 208. Many variant embodiments may bemade to one or more of these features, and various parts may be added oreliminated. Some of these variations are described further below, but nospecific variation(s) should be construed as limiting.

Housing 206 may be flexible or rigid in some variations. In someembodiments, for example, flexible housing 206 may comprise multiplesegments configured such that housing 206 is deformable by tensioning atensioning member coupled to the segments. In some embodiments, housing206 is formed from an elastic material having a geometry selected toengage and optionally shape or constrict the annular tissue. Forexample, the rings may be formed from spring stainless steel,super-elastic shape memory alloys such as nickel-titanium alloys (e.g.,Nitinol), or the like. In other embodiments, the housing 206 could beformed from an inflatable or other structure that can be selectivelyrigidified in situ, such as a gooseneck or lockable element shaft, anyof the rigidifying structures described above, or any other rigidifyingstructure.

In some embodiments of the invention, anchors 210 are generally C-shapedor semicircular in their undeployed form, with the ends of the “C” beingsufficiently sharpened to penetrate tissue. Between the ends of theC-shaped anchor 210, an eyelet may be formed for allowing slidablepassage of the tether 212. To maintain the anchors 210 in theirC-shaped, undeployed state, anchors 210 may be retained within housing206 by two mandrels 214, one mandrel 214 retaining each of the two armsof the C-shape of each anchor 210. Mandrels 214 may be retractablewithin elongate catheter body 204 to release anchors 210 and allow themto change from their undeployed C-shape to a deployed shape. Thedeployed shape, for example, may approximate a partial or completecircle, or a circle with overlapping ends, the latter appearing similarto a key ring. Such anchors are described further below, but generallymay be advantageous in their ability to secure themselves to annulartissue by changing from their undeployed to their deployed shape. Insome variations, anchors 210 are also configured to lie flush with atissue surface after being deployed. By “flush” it is meant that nosignificant amount of an anchor protrudes from the surface, althoughsome small portion may protrude.

The retaining mandrels 214 may have any suitable cross-sectional shape,cross-sectional area, length and be made of any suitable material, suchas stainless steel, titanium, nickel-titanium alloys (e.g., Nitinol), orthe like. Some embodiments may not include a mandrel, or may have onemandrel, two mandrels, or more than two mandrels.

In some embodiments, the anchors 210 may be released from mandrels 214to contact and secure themselves to annular tissue without any furtherforce applied by the delivery device 200. Some embodiments, however, mayalso include one or more expandable members 208, which may be expandedto help drive anchors 210 into tissue. Expandable member(s) 208 may haveany suitable size and configuration and may be made of any suitablematerial(s). Any of a variety of mechanical and hydraulic expandablemembers known in the art may be included in housing 206.

In another embodiment of the invention, shown in FIGS. 12A and 12B, aflexible distal portion of an anchor delivery device 520 includes ahousing 522 configured to house multiple coupled anchors 526 and ananchor contacting member 530 coupled with a pull cord 532. Housing 522may also include multiple apertures 528 for allowing egress of anchors526. For clarity, delivery device 520 is shown without a tether in FIG.12A, but FIG. 12B shows that a tether 534 may extend through an eyelet,loop or other portion of each anchor 526, and may exit each aperture 528to allow for release of the plurality of anchors 526. Anchors 526 may berelatively straight and may lie relatively in parallel with the longaxis of delivery device 522. Anchor contacting member 530, which maycomprise any suitable device, such as a ball, plate, hook, knot,plunger, piston, or the like, generally has an outer diameter that isnearly equal to or slightly less than the inner diameter of housing 522.Contacting member 530 is disposed within the housing, distal to adistal-most anchor 526, and is retracted relative to housing 522 bypulling pull cord 532. When retracted, anchor contacting member 530contacts and applies force to a distal-most anchor 526 to cause releaseof that anchor 526 from housing 522 via one of the apertures 528.Contacting member 530 is then pulled farther proximally to contact andapply force to the next anchor 526 to deploy that anchor 526, and so on.

Retracting contacting member 530 to push anchors 526 out of apertures528 may help cause anchors 526 to secure themselves to the tissueadjacent the apertures 528. Using anchors 526 that are relativelystraighter/flatter configuration when undeployed may allow anchors 526with relatively large deployed sizes to be disposed in (and deliveredfrom) a relatively small housing 522. In one embodiment, for example,anchors 526 that deploy into a shape approximating two intersectingsemi-circles, circles, ovals, helices, or the like, and that have aradius of one of the semi-circles of about 3 mm may be disposed within ahousing 522 having a diameter of about 6 French (2.00 mm) and morepreferably about 5 French (1.67 mm) or even smaller. Such anchors 526may measure about 6 mm or more in their widest dimension. In someembodiments, housing 522 may have a diametrical dimension (“d”) andanchor 526 may have a diametrical dimension (“D”) in the deployed state,and the ratio of D to d may be at least about 3.5. In other embodiments,the ratio of D to d may be at least about 4.4, and more preferably atleast about 7, and even more preferably at least about 8.8. These areonly examples, however, and other larger or smaller anchors 526 may bedisposed within a larger or smaller housing 522. The dimensions of ananchor may vary depending on the particular usage. For example, anchorsused for ventriculoplasty may permit the use of larger anchors thanthose used for annuloplasty due to fewer space constraints in the maincompartment of the ventricles than in the subvalvular spaces.Furthermore, any convenient number of anchors 526 may be disposed withinhousing 522. In one variation, for example, housing 522 may hold about 1to about 20 anchors 526, and more preferably about 3 to about 10 anchors526. Other variations may hold more anchors 526.

Anchor contacting member 530 and pull cord 532 may have any suitableconfiguration and may be manufactured from any material or combinationof materials. In alternative embodiments of the invention, contactingmember 530 may be pushed by a pusher member to contact and deployanchors 526. Alternatively, any of the anchor deployment devices andmethods previously described may be used.

Tether 534, as shown in FIG. 12B, may comprise any of the tethers 534 ortether-like devices already described above, or any other suitabledevice. Tether 534 is generally attached to a distal-most anchor 526 atan attachment point 536. The attachment itself may be achieved via aknot, weld, adhesive, or by any other suitable attachment mechanism.Tether 234 then extends through an eyelet, loop or other similarconfiguration on each of the anchors 526 so as to be slidably coupledwith the anchors 526. In the particular embodiment shown, tether 534exits each aperture 528, then enters the next-most-proximal aperture,passes slidably through a loop on an anchor 526, and exits the sameaperture 528. By entering and exiting each aperture 528, tether 534allows the plurality of anchors 526 to be deployed into tissue andcinched. Alternate embodiments of housing 522, anchors 526 and tether534 may also be used. For example, housing 522 may include alongitudinal slit through which tether 534 may pass, thus allowingtether 534 to reside wholly within housing before deployment.

FIGS. 13A to 13D represent various views of one embodiment of a deliverycatheter 1200 that can be used to deliver one or more anchors to atarget site. As shown in FIG. 13A, delivery catheter 1200 has a distalregion 1204 including a tip 1202, an anchor-holding region 1206including a primary lumen 1208, an intermediate region 1210 includingboth primary lumen 1208 and a secondary lumen 1212, and a proximalregion 1214 including primary lumen 1208. An anchor 1216 is disposedwithin primary lumen 1208, in the anchor-holding region 1206. While onlyone anchor is shown in the anchor-holding region of this embodiment, inother embodiments of the invention, the delivery catheters may includean anchor-holding region that is adapted to hold multiple anchors.Similarly, while the variation shown in FIGS. 13A to 13D depict anchorsadapted to be deployed from distal region 1204 of delivery catheter1200, it should be understood that the anchors may be deployed from anysuitable region of delivery catheter 1200, as desirable. For example, ifdesirable, the anchor may be delivered out of a side port or hole on thedelivery catheter.

As shown in FIGS. 13A to 13D, a tether 1218 may be threaded into a slot1219 of tip 1202 (shown in FIGS. 13C and 13D), and through an eyelet1226 of anchor 1216. After extending through eyelet 1226, tether 1218exits primary lumen 1208, and extends along an exterior surface 1221 ofdelivery catheter 1200 for the remainder of the length of theanchor-holding region, as shown in FIG. 13C. Tether 1218 then enterssecondary lumen 1212, and extends through the length of secondary lumen1212, exiting secondary lumen 1212 at an end of distal region 1214. Anactuator 1220 is slidably disposed within primary lumen 1208, and can beused to push or deploy anchor 1216 out of the primary lumen 1208.Actuator 1220 is in the form of a pushable generally tubular member,although other forms of actuators may be used. For example, in somevariations, a solid rod may be used as an actuator. Once a sufficientdistal portion of anchor 1216 has been displaced out of primary lumen1208, the self-expanding properties of anchor 1216 may cause the biaseddistal ends to expand outwardly and cause the remainder of anchor 1216to “spring out” or “shoot out” of distal end 1202 and facilitate tissuepiercing by anchor 1216. Eyelet 1226 will also engage tether 1218 asanchor 1216 exits delivery catheter 1200. In other embodiments, actuator1220 may be spring-loaded or biased to facilitate tissue piercing.Additional embodiments of the delivery catheter are described in U.S.patent application Ser. No. 11/202,474, which was previouslyincorporated by reference.

Delivery catheter 1200 may optionally comprise a retrieval member, suchas a retrieval line or filament 1222 that is looped around eyelet 1226of anchor 1216 and threaded proximally back through delivery catheter1200. Retrieval filament 1222 is pulled of delivery catheter 1200 byeyelet 1226 when anchor 1216 is deployed. Retrieval filament 1222 may beused to pull back anchor 1216 into delivery catheter 1200 should anchor1216 misfire and fail to engage body tissue. If anchor 1216 issuccessfully deployed, one end of retrieval filament 1222 may be pulledout from eyelet 1226 to release anchor 1216 from retrieval filament1222.

With reference to FIGS. 15A to 15F, one embodiment of the inventioncomprises a method for applying a plurality of tethered anchors 526 tothe annular tissue of a heart. As shown in FIG. 15A, an anchor deliverydevice 520 is first contacted with the valve annulus VA or annulartissue such that openings 528 are oriented to deploy anchors 526 intothe tissue. Such orientation may be achieved by any suitable technique.In one embodiment, for example, a housing 522 having an ellipticalcross-sectional shape may be used to orient openings 528. Contactbetween housing 522 and the annular tissue may be enhanced by expandingexpandable member 524 to wedge housing 522 within the deepest portion ofthe subannular groove region.

Generally, delivery device 520 may be advanced into any suitablelocation for treating any valve or body tissue by any suitable advancingor device placement method. For example, in one embodiment a guidemember is first advanced in a retrograde fashion through an aorta,typically via access from a femoral artery. The guide member is passedinto the left ventricle of the heart and thus into the space formed bythe mitral valve leaflets, the left ventricular wall and chordaetendineae of the left ventricle. Once in this space, the guide member isadvanced along a portion (or all) of the circumference of the mitralvalve. A sheath 540 is advanced over the guide member within the spacebelow the valve leaflets, and the guide element is removed throughsheath 540. In some embodiments, the guide member may comprise asteerable guide catheter. Anchor delivery device 520 may then beadvanced through the sheath to a desired position within the space, andsheath 540 may be removed. In other embodiments, a tunnel catheter 148(shown in ghost) is passed through the sheath to provide additionalstability and to facilitate positioning of the delivery device 520.

As shown in FIG. 15B, when delivery device 520 is positioned in adesired location for deploying anchors 526, anchor contacting member 530is retracted to contact and apply force to a most-distal anchor 526 tobegin deploying anchor 526 through aperture 528 and into the valveannulus VA or annular tissue. FIG. 15C shows anchor 526 further deployedout of aperture 528 and into valve annulus VA or annular tissue. FIG.15D shows the valve annulus VA transparently so that further deploymentof anchors 526 can be seen. As shown, in one embodiment, anchors 526include two tips that move in opposite directions upon release fromhousing 522 and upon contacting the valve annulus VA or annular tissue.Between the two tips, an anchor 526 may be looped or have any othersuitable eyelet or other device for allowing slidable coupling with atether 534.

Referring now to FIG. 15E, anchors 526 are seen in their fully deployedor nearly fully deployed shape, with each tip (or “arm”) of each anchor526 having curved to form a circle or semi-circle. In some variationsanchors 526 may have any other suitable deployed and undeployed shapes,as described more fully above. FIG. 15F shows anchors 526 deployed intothe valve annulus VA or annular tissue and coupled to tether 534, withthe distal-most anchor 526 coupled to tether 524 at attachment point536. At this stage, tether 534 may be tensioned to tighten the annulartissue, thus reducing valve regurgitation. In some embodiments, valvefunction may be monitored by means such as echocardiogram and/orfluoroscopy, and tether 534 may be tensioned, loosened, and adjusted toachieve a desired amount of tightening as evident via the employedvisualization technique(s). When a desired amount of tightening isachieved, the implant may be fixed using any of a variety of terminationdevices and methods.

For example, in one embodiment, tensioning tether 534, attaching tether534 to most-proximal anchor 526, and cutting tether 534 are achievedusing a termination device (not shown). The termination device maycomprise, for example, a catheter advanceable over tether 534 thatincludes a cutting member and a nickel-titanium alloy (e.g., Nitinol)knot or other attachment member for attaching tether 534 tomost-proximal anchor. The termination catheter may be advanced overtether 534 to a location at or near the proximal end of the tetheredanchors 526. It may then be used to apply opposing force to themost-proximal anchor 526 while tether 534 is tensioned. Attachment andcutting members may then be used to attach tether 534 to most-proximalanchor 526 and cut tether 534 just proximal to most-proximal anchor 526.Such a termination device is only one possible way of accomplishing thecinching, attachment and cutting steps, and any other suitable device(s)or technique(s) may be used. Additional devices and methods forterminating (e.g., cinching and fastening) may be found, for example, inU.S. patent application Ser. No. 11/232,190, previously incorporated byreference, and U.S. patent application Ser. No. 11/270,034, and Ser. No.11/875,774, both of which are herein incorporated by reference in theirentirety. In some embodiments, the termination device is located in thesame heart chamber as the remaining portions of the implant, whichpermits the implant to be wholly implanted in a single heart chamber. Inother embodiments, however, a portion of the implant passes transmurallythrough a septal wall or an outer wall of a heart chamber. In theseembodiments, the termination member and optionally one or more anchorsmay be located in a different heart chamber.

In some embodiments, it may be advantageous to deploy a first number ofanchors 526 along a first portion of annular tissue, cinch the firstanchors to tighten that portion of the annular tissue, move the deliverydevice 520 to another portion of the annular tissue, and deploy andcinch a second number of anchors 526 along a second portion of theannular tissue. Such a method may be more convenient, in some cases,than extending delivery device 520 around all or most of thecircumference of the annular tissue, and may allow a shorter, moremaneuverable housing 522 to be used.

With reference to FIGS. 16A and 16B, a diagrammatic representation ofanother embodiment of the invention, comprising coupled anchors isshown. Here, anchors 510 are coupled to a self-deforming or deformablecoupling member or backbone 505. This backbone 505 is another embodimentof a tether. The backbone 505 may be fabricated, for example, fromnickel-titanium alloys (e.g., Nitinol), spring stainless steel, or thelike, and may have any suitable size or configuration. In oneembodiment, as in FIG. 16A, backbone 505 is shaped as a generallystraight line when held in an undeployed state, such as when restrainedwithin a housing of an anchor deliver device. When released from thedelivery device, backbone 505 may change to a deployed shape havingmultiple bends, as shown in FIG. 16B. By bending, backbone 505 shortensthe longitudinal distance between anchors, as demonstrated by thesolid-tipped arrows in FIG. 16B. This shortening process may act toreshape any tissue or structure into which anchors 510 have beensecured. Thus, anchors 510 coupled to backbone 505 may be used toreshape annular tissue or any other tissue without using a separatetether or applying tethering force. In other embodiments, an elastictether may be used as the backbone 505. In still other embodiments,backbone may also be coupled with a termination member to further cinchthe annular tissue. In such an embodiment, the backbone 505 is adaptedto be at least partially conformable or cinchable, such that when forceis applied to anchors 510 and backbone 505 via a tether, backbone 505buckles or compresses further to allow further cinching of the annulartissue.

Although the preferred access route to the subannular groove region 104or subvalvular space 106 is a retrograde route through the aorta A tothe heart H, other access routes may also be used. Access to the heart Hmay also be transthoracic, with a delivery device being introduced intothe heart via an incision or port in the heart wall. Even open heartsurgical procedures may benefit from the methods and devices describedherein. In some embodiments of the invention, hybrid access involving acombination of access methods described herein may be used. In onespecific example, dual access to a valve may be achieved with acombination of venous and arterial access sites. User manipulation ofboth ends of a guidewire placed across a valve may improve positioningand control of the catheter and the implants. In other examples ofhybrid access, both minimally invasive and surgical access is used toimplant one or more cardiac devices.

Other embodiments of the invention also include treatment of thetricuspid valve annulus, tissue adjacent the tricuspid valve leafletsTVL, or any other cardiac or vascular valve. Thus, although thedescription herein discloses specific examples of devices and methods ofthe invention for mitral valve repair, the devices and methods of theinvention may be used in any suitable procedure, both cardiac andnon-cardiac. For example, in other embodiments of the invention, themitral valve reshaping devices and procedures may be used with thetricuspid valves also, and certain embodiments may also be adapted foruse with the pulmonary and aortic valves. Likewise, the other examplesprovided below are directed to the left ventricle, but the devices andmethods may also be adapted by one of ordinary skill in the art for usein the right ventricle or either atrium. The devices and methods mayalso be used with the great vessels of the cardiovascular system, forexample, to treat aortic root dilatation.

Access to the other chambers of the heart may be performed throughpercutaneous or venous cut-down access, including but not limited totransjugular, subclavicular and femoral vein access routes. When venousaccess is established, access to the right atrium RA, the rightventricle RV, the tricuspid valve TV and other right-sided cardiacstructures can occur. Furthermore, access to left-sided heartstructures, such as the left atrium LA, left ventricle LV, mitral valveand the aortic valve, may be subsequently achieved by performing atransseptal puncture procedure. Referring to FIG. 17 with a heart H isshown in cross section, transseptal puncture is traditionally performedusing a Mullins introducer sheath with a Brockenbrough curved needlethrough the interatrial septum to access the left atrium LA, but any ofa variety of other transseptal puncture devices or kits may also beused. After puncturing through the left atrium LA, supravalvular accessto the mitral valve is achieved. Antegrade access to the left ventricleLV can also occur by crossing the mitral valve. Similarly, access fromthe right ventricle RV to the left ventricle LV may be obtained bytransseptal puncture of the ventricular septum. In still otherembodiments, a catheter device may access the coronary sinus and a valveprocedure may be performed directly from the sinus.

Surgical approaches that may be used have been described above but alsoinclude but are not limited to transcatheter procedures made throughsurgical incisions in the aorta or myocardium. In one particularembodiment, depicted in FIG. 18, a transapical approach with a surgicaldelivery device 114 is utilized, to provide a more linear route to thesubvalvular space 106. The transapical approach also reduces potentialeffects of a myocardial incision on cardiac output, as the apical wall112 typically contributes less mechanical effect on left ventricularejection fraction compared to other sections of the myocardial wall.

In addition to performing valve annuloplasty with the multi-openingguide tunnel, other uses, including cardiac and non-cardiacapplications, are contemplated within the scope of the invention. In oneembodiment of the invention, reconfiguration of the subvalvularapparatus with a cinchable implant delivered by a multi-opening deliverytool with a releasable tether retaining mechanism is contemplated. Forexample, a plurality of tethered anchors may be secured to themyocardium adjacent the papillary muscle and then cinched to tension themyocardium and cause repositioning of one or more papillary muscles.

In other embodiments, the reshaping of a ventricle may be performedusing a multi-opening guide tunnel with a releasable tether retainingmechanism, along any of a variety of dimensions or vectors. For example,referring to FIG. 19, in some embodiments of the invention, thereshaping of a ventricle or a valve may occur with respect to thediameter B or the circumference C about a valve orifice. In onepreferred embodiment, the diameter B and the circumference C withrespect to the subannular groove region 104 of a ventricle is reshaped.In addition to the reshaping of to valvular structures, reshaping canalso be performed with respect to the non-valvular structures of a heartchamber. For example, one or more of the diameters or circumferences ofthe ventricle may be reshaped. As shown in FIG. 19, the diameter B′ andthe circumference C′ of the ventricle located generally at or above thepapillary muscles may be reshaped. The diameter B″ and circumference C″of the ventricle at or below the papillary muscles may also be reshaped.The orientation of the diameter and circumference that is reshaped orassessed can vary, but in some embodiments, the diameter orcircumference may be in a generally perpendicular orientation withrespect to a longitudinal axis of a ventricle. One of skill in the artwill understand that the longitudinal axis may be characterized in anumber of ways, including but not limited to a longitudinal axis from avalve orifice to an apex of a heart chamber, or from the apex of a heartchamber to a point that generally splits the ventricular volume in half.Similarly, some of the implantation dimensions or vectors may also beoriented with respect to the anterior-posterior axis or thesepto-lateral axis of the heart chamber.

Referring to FIG. 20, in some embodiments, the myocardium along vectorsA, D between a papillary muscle and a valve leaflet may be reshaped.Vectors D or A may be between a papillary muscle and its associatedvalve leaflet, or between a papillary muscle and an unassociated valveleaflet, respectively. Although the vectors A, D depicted in FIG. 20 areshown from the tip of the papillary muscle, these pathways may also beassessed from the base of the papillary muscle. Similarly, myocardialpathways including a valve leaflet may be assessed from the distalmostsection, the middle or the base of the valve leaflet. In otherembodiments, the reshaping of the heart may occur between the apex of aheart chamber and one or more valves. For example, reshaping may occuralong the vector E between the outlet valve and the apex of a heartchamber, and/or along the pathway F between the inlet valve and theapex.

In FIG. 21, for example, a multi-opening guide tunnel 850 with latches852 is used to place a cinchable implant 854 along vector E from FIG.20. To implant a ventricular device in a beating heart, in someembodiments of the invention one end of the implant is preferably firstattached to a less mobile portion of the ventricle chamber. The distalend 856 of the implant 854 is first secured to the apical region 858 ofthe left ventricle LV. Once the distal end 856 of the implant 854 isstabilized, guide tunnel 850 can be stabilized using the secured distalend 854 and provide increased stability during the procedure byreleasably retaining portions of the tether 860 as the remaining anchorsare deployed.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

What is claimed is:
 1. A method for performing a procedure inside aheart comprising: positioning a multi-aperture catheter adjacent toheart tissue, the multi-aperture catheter comprising a lumen at leastpartially therethrough and a plurality of apertures defined by aplurality of latches, wherein the plurality of latches are locked;advancing a device comprising at least one anchor coupled to a tether atleast partially through the lumen, wherein the plurality of latchesretain the tether within the lumen; temporarily securing themulti-aperture catheter to the heart tissue using the device; unlockingthe plurality of latches to release the tether from the lumen;withdrawing the multi-aperture catheter from the heart tissue, whereinat least a portion of the device remains secured to the heart tissue;and removing the multi-aperture catheter from the heart.
 2. The methodof claim 1 wherein the multi-aperture catheter further comprises atleast one locking element configured to lock the plurality of latches.3. The method of claim 2 wherein unlocking the plurality of latchescomprises withdrawing the at least one locking element.
 4. The method ofclaim 1 wherein the plurality of openings are located along a length ofthe multi-aperture catheter.
 5. The method of claim 1 wherein themulti-aperture catheter is positioned adjacent to the heart tissue usingan intravascular approach.
 6. The method of claim 1 wherein themulti-aperture catheter is positioned adjacent to the heart tissue usinga surgical technique.
 7. The method of claim 1 wherein themulti-aperture catheter is positioned adjacent to the heart tissue usingport access to the heart.
 8. The method of claim 1 wherein the hearttissue is ventricular tissue.
 9. The method of claim 1 wherein the hearttissue is within the subannular groove region.
 10. The method of claim 1wherein the heart tissue is within the subvalvular space.
 11. The methodof claim 1 wherein the multi-aperture catheter is temporarily secured toheart tissue using the at least one anchor coupled to a tether.
 12. Themethod of claim 1 wherein the device is deployed through the pluralityof openings.
 13. The method of claim 1 wherein the multi-aperturecatheter comprises at least a first opening and a second opening, bothopenings positioned along a length of the multi-aperture catheter. 14.The method of claim 13 wherein the device comprises at least a firstanchor and a second anchor, at least one of the first or second anchorsbeing fixedly coupled to the tether.
 15. The method of claim 14 whereinthe first anchor is deployed through the first opening and the secondanchor is deployed through the second opening.
 16. The method of claim15 wherein at least one of the first or second anchors is slidablycoupled to the tether.
 17. The method of claim 16 further comprisingtensioning the tether.
 18. The method of claim 17 further comprisingsecuring the tether in its tensioned state.
 19. The method of claim 18further comprising cutting the tether.